The pyrimidine compound with which the present invention is concerned has the following structural formula ##STR1## and is known as gepirone. The hydrochloride salt has been referred to in the prior art as MJ 13805-1 and as gepirone hydrochloride. Other acid addition salts thereof are named by combining "gepirone" with the appropriate word to define the acid from which it is prepared as in "gepirone hydrochloride". The latter is the U.S. adopted name (USAN); refer to the "1986 USAN and the USP Dictionary of Drug Names" which is published by the United States Pharmacopeial Convention, Inc.
The synthesis of the compound and the disclosure of its anxiolytic properties are described in the following patents and publications.
1. D. L. Temple, Jr., U.S. Pat. No. 4,423,049, issued Dec. 27, 1983. PA0 2. Annual Reports in Medicinal Chemistry: Volume 21, Editor-in-Chief D. M. Bailey, Academic Press, Inc., 1986, Pages 15, 43. PA0 3. Eison, et al., Eur. J. Pharmacol., III: 389-392 (1985). PA0 4. Eison, et al., Drugs of the Future, 10: 456-457 (1985). PA0 6. D. V. Sheehan, "Panic Attacks and Phobias", New England J. of Med., 307, pp. 156-158 (1982). PA0 7. R. I. Shoder, et al., "Panic Disorders: Current Perspectives", J. Clin. Psychopharmacology, 2/6 Supplement, pp. 25-265 (1982). PA0 8. W. Matuzas, et al., "Treatment of Agoraphobia and Panic Attacks", Arch. Gen. Psychiatry, 40, pp. 220-222 (1983).
Gepirone has also been reported to be an anxiolytic agent with antidepressant properties as disclosed in the following representative references.
The method of the present invention can be distinguished from the above prior art in that it is directed to a distinct patient population characterized by a disease state different from that related to anxiety and anxiety with mixed depression disclosed in this prior art. Support for this distinction is found in reference 5, "The Diagnostic Validity of Anxiety Disorders and Their Relationship to Depressive Illness", by A. B. Boyer, et al. in Am. J. Psychiatry, 142: 7, pp. 787-796 (1985).
Although panic disorder is a relatively new diagnosis, the basic diagnostic concepts are well known to those skilled in the art and are clearly differentiated from generalized, persistent anxiety states. The following references are examples of literature reviewing the diagnosis and treatment of panic disorders.
A possibly relevant disclosure is our own earlier invention of U.S. Pat. No. 4,634,703 which issued Jan. 6, 1987 in which another pyrimidine compound, buspirone, was disclosed and claimed as being useful in the treatment of panic disorders. We believe that upon consideration of all applicable prior art that there is no teaching or suggestion that the instant compounds would be useful in alleviation of panic disorder.